INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients

NCT07283783 | Recruiting

• 1 other identifier: 202511072
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will evaluate the feasibility of the Wellness Program, including patient recruitment, screening and outcome measures, and feasibility of adapting the intervention with older Black surgical patients who endorse clinically significant symptoms of depression and/or anxiety.

Conditions

Surgery

Keywords

Perioperative Care; Minority Mental Health; Anxiety; Depression; Polypharmacy; Behavioral Treatment; Medication Counseling; Coordination

Outcome Measures

Primary Outcomes (2)

• Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate

  Through completion of enrollment for all participants (estimated to be 9 months, time for participant 1 day)

• Reach of the intervention as measured by number of patients who completed the intervention out of patients who agreed to participate in the study

  Through completion of follow-up for all participants (estimated to be 12 months, time for participant 3 months)

Secondary Outcomes (1)

• Percentage of instrument or data fields completed for Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

  Baseline, 1 month after surgery, and 3 months after surgery

Study Arms (1)

Wellness Program for Perioperative Mental Health

EXPERIMENTAL

Enrolled participants will participate in the study for approximately 3 months after surgery. The participants will complete questionnaires at baseline, 1 month after surgery, and 3 months after surgery. The Wellness Program will consist of Cognitive Behavioral Therapy (CBT) and medication optimization.

Behavioral: Wellness Program

Interventions

Wellness Program BEHAVIORAL

The BCBT intervention consists of 8 to 10 structured sessions delivered remotely via phone or Zoom, beginning in the preoperative period and continuing for approximately three months after surgery. The interventionist will offer a protocolized review of current medications with feedback as appropriate, under guidance by the study psychiatrist. As additional optional components of the Wellness Program, the study team will also offer faith-based counseling as well as the option to involve family and friends as active or passive participants in the program.

Wellness Program for Perioperative Mental Health

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years
• Scheduled surgical procedure at BJH or BJWCH (oncologic, cardiac; orthopedic)
• Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10
• Black or African American.

You may not qualify if:

• Inability to provide informed consent;
• Severe cognitive impairment screened by the SBT (Short Blessed Test) ≥10
• Acutely suicidal
• Considered ineligible per the discretion of the surgeon or study PI
• Considered ineligible per the discretion of the surgeon or study PI
• Caregiver participants:
• If patients identify a caregiver that the patient would like to include in their Wellness Program, the caregiver will be invited to consent. Patients will provide contact information for their caregiver.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joanna Abraham, Ph.D., FACMI, FAMIA

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Meng, MA

CONTACT

314-273-5016; aliciameng@wustl.edu

Joanna Abraham, Ph.D., FACMI, FAMIA

CONTACT

314-362-5129; joannaa@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers must provide a methodologically sound proposal that meets the approval of the author. Proposals should be directed to joannaa@wustl.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available to the requestor indefinitely via encrypted e-mail service.

Locations

US (1)